COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073866
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : July 19, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: celecoxib Drug: docetaxel Drug: irinotecan hydrochloride Phase 1 Phase 2

Detailed Description:


  • Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the response rate of patients treated with this regimen.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen.
  • Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.

  • Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
  • Phase II: Patients receive treatment as in phase I at the recommended phase II dose.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer
Study Start Date : June 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Stage IV
    • Stage IIIB with a malignant pleural effusion
    • Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy
  • Unidimensionally measurable disease

    • If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area
  • No CNS metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal)
  • Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal)


  • Creatinine less than 2.0 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study treatment
  • No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
  • No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80
  • No pre-existing grade 2 or greater peripheral neuropathy
  • No concurrent medical condition that would preclude study compliance


Biologic therapy

  • At least 1 week since prior biologic therapy
  • Phase I patients:

    • Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors)
  • Phase II patients:

    • No prior biologic therapy for recurrent/metastatic disease
  • No concurrent filgrastim (G-CSF)


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No prior irinotecan or docetaxel
  • Phase I patients:

    • Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible)
  • Phase II patients:

    • At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease
    • No prior chemotherapy for recurrent/metastatic disease

Endocrine therapy

  • Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months


  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease


  • Recovered from prior surgery


  • More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis
  • No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days
  • No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole
  • No concurrent NSAIDs
  • No other concurrent COX-2 inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073866

Layout table for location information
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Silver Cross Hospital
Joliet, Illinois, United States, 60432
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Athanassios Argiris, MD Robert H. Lurie Cancer Center
Publications of Results:
Layout table for additonal information
Responsible Party: Northwestern University Identifier: NCT00073866    
Other Study ID Numbers: NU 01L2
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: July 2012
Keywords provided by Northwestern University:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors